复方罗布麻片Ⅰ溶出度考察  

Dissolution Determination of Compound Kendir Leaves Tablets Ⅰ

作　　者：李海剑 谢莹霞 张军霞[3] Li Haijian;Xie Yingxia;Zhang Junxia(Henan Provincial Food and Drug Evaluation and Inspection Center,Zhengzhou,Henan,China 450000;Shangqiu First People＇s Hospital,Shangqiu,Henan,China 476100;Henan Provincial Institute of Food and Drug Control,Zhengzhou,Henan,China 450000)

机构地区：[1]河南省食品药品审评查验中心,河南郑州450000 [2]河南省商丘市第一人民医院,河南商丘476100 [3]河南省食品药品检验所,河南郑州450000

出　　处：《中国药业》2018年第15期27-29,共3页China Pharmaceuticals

基　　金：2017年河南省科技研发专项[162102310067]

摘　　要：目的建立复方罗布麻片Ⅰ的溶出度考察方法,测定制剂中氢氯噻嗪的溶出度。方法色谱柱采用Eclipse XDB-C_(18)柱(150mm×4.6mm,5μm),流动相为乙腈-水(12∶88),流速为1.0mL/min,检测波长为271nm,进样量为10μL,柱温为30℃。考察不同溶出介质、转速下复方罗布麻片Ⅰ中氢氯噻嗪的溶出情况。结果 0.1 mol/L的盐酸600mL为溶出介质,转速为100r/min溶出条件下,溶出度好。结论该方法简便、准确,结果可靠,可用于复方罗布麻片Ⅰ的质量控制。Objective To establish a method for dissolution determination of Compound Kendir Leaves Tablets Ⅰ, and determine the dissolution of hydrochlorothiazide in this preparation.Methods The chromatographic column was Eclipse XDB-C18 column（ 150mm×4.6mm,5μm）,the mobile phase was acetonitrile-water（12∶88）,the flow rate was 1.0mL/min,the detection wavelength was 271 nm,the sample size was 10 μL, the column temperature was 30℃.The dissolubility of hydrochlorothiazide in Compound Kendir Leaves TabletsⅠ was determined with different dissolution mediums and different rotation speeds.Results The dissolution of Compound Kendir Leaves TabletsⅠ was good with 600mL 0.1mol/L hydrochloric acid as dissolution media and paddle rotation at the speed of 100r/min.Conclusion This method is simple and accurate with reliable result, which can be used for the quality control of Compound Kendir Leaves TabletsⅠ.

关 键 词：复方罗布麻片Ⅰ 氢氯噻嗪 溶出度 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]